On 1 May 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Linerixibat (brand name Lynavoy) for treating itch in adults with primary biliary cholangitis (PBC). The drug is an orally administered film‑coated tablet, given at 40 mg twice daily. The approval follows the global Phase 3 Glisten trial, which enrolled 238 patients and showed a significant reduction in itch and improvement in sleep disruption compared with placebo. The primary outcome was the Monthly Itch Score, which improved statistically with Linerixibat. The MHRA will continue to monitor safety and effectiveness as the medicine is used more widely. GlaxoSmithKline UK Limited holds the approval, and additional safety information is available in the product literature.
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Summary adapted from content licensed under the Open Government Licence v3.0.
For details, see https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/.
Original source: https://www.gov.uk/
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